Elinzanetant (BAY3427080) Clinical Trials (2026): 18 Studies for Hot Flashes & Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
Synced daily from ClinicalTrials.gov via AACT. Last sync: .
18 Elinzanetant (BAY3427080) clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 6 indications (including Hot Flashes & Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men) and 2,611 total planned enrollment. 4 Phase 3 Elinzanetant (BAY3427080) trials and 3 Phase 2 are listed. 1 Elinzanetant (BAY3427080) clinical trial is actively recruiting at 2 U.S. sites across 1 state. Most recent activity: NCT07077395 (Sep 2029).
Where to Participate: All Elinzanetant (BAY3427080) Trial Sites in the U.S. (2 sites across 1 state)
Every actively recruiting Elinzanetant (BAY3427080)trial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| MA | Brigham and Women's Hospital | Boston02115 | NCT07077395 | Map |
| MA | Massachusetts General Hospital | Boston02114 | NCT07077395 | Map |
Elinzanetant (BAY3427080) clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | completed | Total |
|---|---|---|---|---|
| P1 | 11 | 11 | ||
| P2 | 1 | 2 | 3 | |
| P3 | 1 | 3 | 4 |
Recruiting Elinzanetant (BAY3427080) clinical trials (1)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT07077395 | FLASH-CV:Finding Links Between Hot flASHes and CardioVascular Disease | P2 | Menopause-related Hot Flashes | 80 | Mar 2026 |
Elinzanetant (BAY3427080) clinical trials by indication
Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men (11)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06219902 | — | P1 | completed | A Study to Learn if Elinzanetant Affects the Ability to Drive and Brain Function in Healthy Women |
| NCT05481528 | — | P1 | completed | A Study to Learn How Safe the Study Treatment Elinzanetant is and How it Moves Into, Through and Out of the Body When Given as Single Increasing Doses That Are Higher Than Normally Used Compared to Placebo and Moxifloxacin in Healthy Participants |
| NCT05471817 | BAY 3427080 | P1 | completed | A Study to Learn How the Study Drug Elinzanetant (BAY 3427080) Affects the Way the Drug Dabigatran Moves Into, Through and Out of the Body in Healthy Male and Female Participants |
| NCT05071729 | — | P1 | completed | A Study to Learn How Elinzanetant Moves Into, Through, and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Kidneys That do Not Work as Well as They Should Compared to Participants Whose Kidneys Work Normally |
| NCT05381142 | — | P1 | completed | A Study to Learn More About How the Study Treatment Elinzanetant (or BAY3427080) Moves Into, Through and Out of the Body, How Safe it is and How it Affects the Body After Taking Single and Multiple Doses in Healthy Women Aged 40 to 65 Years |
| NCT05351892 | — | P1 | completed | A Study to Learn More About How Much of the Study Treatment Elinzanetant (or BAY3427080) Gets Absorbed, How Safe it is and How it Affects the Body in Healthy Female and Male Participants |
| NCT04981431 | — | P1 | completed | A Study to Learn How Safe Elinzanetant is, How it Affects the Body, and How it Moves Into, Through and Out of the Body After Single and Multiple Doses in Japanese Healthy Female Adults |
| NCT05061563 | BAY 3427080 | P1 | completed | A Study to Learn How a Proton Pump Inhibitor Affects the Way Elinzanetant (BAY 3427080) Moves Into, Through and Out of the Body, and How Much of it Gets Absorbed by the Body When Taken as a Single and Small Radioactive Dose in Healthy Adults |
| + 3 more, see All trials below. | ||||
Vasomotor Symptoms Associated With Menopause (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05030584 | OASIS-3 | P3 | completed | A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 52 Weeks in Women Who Have Been Through the Menopause |
| NCT05042362 | OASIS-1 | P3 | completed | A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause |
| NCT05099159 | OASIS-2 | P3 | completed | A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2) |
Menopause-related Hot Flashes (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07077395 | FLASH-CV: | P2 | recruiting | Finding Links Between Hot flASHes and CardioVascular Disease |
Sleep Disturbances Associated With Menopause (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06112756 | NIRVANA | P2 | completed | A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause |
Vasomotor Symptoms Caused by Adjuvant Endocrine Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05587296 | OASIS-4 | P3 | active not recruiting | A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer |
Menopause (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03596762 | SWITCH-1 | P2 | completed | A Study of BAY3427080 (NT-814) in the Treatment of Moderate to Severe Post-menopausal Vasomotor Symptoms |
Elinzanetant (BAY3427080) pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| OASIS-4 | NCT05587296 | P3 | active not recruiting | Vasomotor Symptoms Caused by Adjuvant Endocrine Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer | 474 | PMID 40454634 |
| OASIS-3 | NCT05030584 | P3 | completed | Vasomotor Symptoms Associated With Menopause | 628 | PMID 40920404 |
| OASIS-1 | NCT05042362 | P3 | completed | Vasomotor Symptoms Associated With Menopause | 396 | PMID 39172446 |
| OASIS-2 | NCT05099159 | P3 | completed | Vasomotor Symptoms Associated With Menopause | 400 | — |
| FLASH-CV: | NCT07077395 | P2 | recruiting | Menopause-related Hot Flashes | 80 | — |
| NIRVANA | NCT06112756 | P2 | completed | Sleep Disturbances Associated With Menopause | 110 | — |
| SWITCH-1 | NCT03596762 | P2 | completed | Menopause | 199 | — |
All Elinzanetant (BAY3427080) trials (18)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT07077395 | FLASH-CV: | Finding Links Between Hot flASHes and CardioVascular Disease | P2 | recruiting | 80 | Massachusetts General Hospital | Mar 2026 |
| NCT05587296 | OASIS-4 | A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer | P3 | active not recruiting | 474 | Bayer | Oct 2022 |
| NCT06112756 | NIRVANA | A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause | P2 | completed | 110 | Bayer | Nov 2023 |
| NCT06219902 | A Study to Learn if Elinzanetant Affects the Ability to Drive and Brain Function in Healthy Women | P1 | completed | 64 | Bayer | Jan 2024 | |
| NCT05030584 | OASIS-3 | A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 52 Weeks in Women Who Have Been Through the Menopause | P3 | completed | 628 | Bayer | Aug 2021 |
| NCT05042362 | OASIS-1 | A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause | P3 | completed | 396 | Bayer | Aug 2021 |
| NCT05099159 | OASIS-2 | A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2) | P3 | completed | 400 | Bayer | Oct 2021 |
| NCT05481528 | A Study to Learn How Safe the Study Treatment Elinzanetant is and How it Moves Into, Through and Out of the Body When Given as Single Increasing Doses That Are Higher Than Normally Used Compared to Placebo and Moxifloxacin in Healthy Participants | P1 | completed | 51 | Bayer | Aug 2022 | |
| NCT05471817 | BAY 3427080 | A Study to Learn How the Study Drug Elinzanetant (BAY 3427080) Affects the Way the Drug Dabigatran Moves Into, Through and Out of the Body in Healthy Male and Female Participants | P1 | completed | 20 | Bayer | Aug 2022 |
| NCT05071729 | A Study to Learn How Elinzanetant Moves Into, Through, and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Kidneys That do Not Work as Well as They Should Compared to Participants Whose Kidneys Work Normally | P1 | completed | 31 | Bayer | Oct 2021 | |
| NCT05381142 | A Study to Learn More About How the Study Treatment Elinzanetant (or BAY3427080) Moves Into, Through and Out of the Body, How Safe it is and How it Affects the Body After Taking Single and Multiple Doses in Healthy Women Aged 40 to 65 Years | P1 | completed | 16 | Bayer | May 2022 | |
| NCT05351892 | A Study to Learn More About How Much of the Study Treatment Elinzanetant (or BAY3427080) Gets Absorbed, How Safe it is and How it Affects the Body in Healthy Female and Male Participants | P1 | completed | 18 | Bayer | May 2022 | |
| NCT04981431 | A Study to Learn How Safe Elinzanetant is, How it Affects the Body, and How it Moves Into, Through and Out of the Body After Single and Multiple Doses in Japanese Healthy Female Adults | P1 | completed | 62 | Bayer | Aug 2021 | |
| NCT05061563 | BAY 3427080 | A Study to Learn How a Proton Pump Inhibitor Affects the Way Elinzanetant (BAY 3427080) Moves Into, Through and Out of the Body, and How Much of it Gets Absorbed by the Body When Taken as a Single and Small Radioactive Dose in Healthy Adults | P1 | completed | 14 | Bayer | Sep 2021 |
| NCT05028608 | A Study to Learn What Happens to Elinzanetant in the Body When Taken With or Without Carbamazepine, and How Safe it is in Healthy Men and Women Aged 18 to 60 Years. | P1 | completed | 16 | Bayer | Sep 2021 | |
| NCT04889287 | A Study to Learn How Much Rosuvastatin Gets Into the Blood When Taken With or Without Elinzanetant and to Learn About the Safety of Elinzanetant in Healthy Participants | P1 | completed | 16 | Bayer | May 2021 | |
| NCT04845841 | Comparison of the Extent to Which the Drug Given as Two Different Capsule Sizes Becomes Available to the Body | P1 | completed | 16 | Bayer | Apr 2021 | |
| NCT03596762 | SWITCH-1 | A Study of BAY3427080 (NT-814) in the Treatment of Moderate to Severe Post-menopausal Vasomotor Symptoms | P2 | completed | 199 | Bayer | Nov 2018 |
Elinzanetant (BAY3427080) clinical trials: frequently asked questions
- How many Elinzanetant (BAY3427080) clinical trials are there?
- 18 Elinzanetant (BAY3427080) clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 1 is actively recruiting participants. 16 are marked completed.
- Are Elinzanetant (BAY3427080) clinical trials recruiting in 2026?
- Yes — 1 Elinzanetant (BAY3427080) trial is actively recruiting in 2026, with 2 U.S. sites across 1 state. See the recruiting trials and the per-state site list further down this page.
- What conditions is Elinzanetant (BAY3427080) being studied for?
- Elinzanetant (BAY3427080) is being studied for Hot Flashes, Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, Healthy Volunteers, Vasomotor Symptoms Associated With Menopause, Sleep Disturbances Associated With Menopause and 4 more. The trials are grouped by indication on this page.
- What phase is Elinzanetant (BAY3427080) in?
- Elinzanetant (BAY3427080) clinical trials span 4 Phase 3, 3 Phase 2, 11 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Elinzanetant (BAY3427080) clinical trials?
- The lead sponsor across the most Elinzanetant (BAY3427080) trials is Bayer, with 1 additional lead sponsor listed in the data. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Elinzanetant (BAY3427080)as an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
Last refreshed .
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